Amgen, Inc. (AMGN - Free Report) and partner UCB S.A. announced results from the pivotal phase III BRIDGE study which showed that its pipeline candidate, romosozumab, significantly increases bone mineral density in men with osteoporosis.
Romosozumab is a monoclonal antibody against sclerostin that is being developed for osteoporosis in partnership with UCB.
BRIDGE (n=245) is a placebo-controlled study evaluating the efficacy and safety of romosozumab in treating men with osteoporosis. The study met the primary endpoint, showing a statistically significant increase in bone mineral density (BMD) at the lumbar spine (as assessed by dual energy x-ray absorptiometry) in men with osteoporosis treated with romosozumab compared with placebo at 12 months. Secondary endpoints were also met as the romosozumab arm led to a statistically significant increase in BMD at total hip and the femoral neck at 12 months versus the placebo arm. The romosozumab arm also showed a statistically significant increase in BMD at six months compared to placebo the arm. Top-line results from the study were announced in March.
Osteoporosis being more common in women, goes undertreated in men. According to the company’s press release, one in five men over the age of 50 worldwide has an osteoporosis-related fracture. The latest phase III data shows the clinical benefits of romosozumab in men with osteoporosis. If the drug is approved for this indication can add to the company’s top-line significantly.
Romosozumabis under review in the U.S. for the treatment of osteoporosis in postmenopausal women. The Biologic License Application (BLA) was submitted in July and accepted by the FDA in September based on data from the pivotal phase III placebo-controlled fracture study in postmenopausal women with osteoporosis (FRAME). The FDA has set a Prescription Drug User Fee Act (PDUFA) for romosozumab with a target action date of Jul 19, 2017.
Romosozumab is currently in another phase III study (a Fosamax (alendronate)-controlled study) with data due next year. Fosamax is marketed by Merck & Co., Inc. (MRK - Free Report) .
Last week, Amgen also announced that the European commission granted a marketing approval to its other pipeline drug, Parsabiv, for the treatment of secondary hyperparathyroidism (SHPT) in adult chronic kidney disease (CKD) patients on dialysis. The approval was not unexpected as the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion to Parsabiv for the SHPT indication in September. However, in the U.S., Amgen received a Complete Response Letter (CRL) from the FDA in August for its new drug application (NDA) for Parsabiv.
Amgen currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Anika Therapeutics Inc. (ANIK - Free Report) with a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates have increased 5% for 2016 and 3% for 2017 over the last 30 days. The company posted a positive earnings surprise in each of the trailing four quarters, with an average beat of 33.1%. Its share price has increased 19% year to date.
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